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Study on Imatinib for Patients with Triple Negative Breast Cancer to Convert it to ER-Positive Breast Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of breast cancer known as triple negative breast cancer. This form of cancer does not have receptors for estrogen, progesterone, or HER2, which are common targets for cancer treatments. The study is exploring the use of a medication called Imatinib, which is taken orally in the form of a hard capsule. Imatinib is a type of drug known as a protein tyrosine kinase inhibitor, which works by blocking certain proteins that can promote the growth of cancer cells.

The purpose of the study is to see if Imatinib can change triple negative breast cancer into a type that has estrogen receptors, known as ER-positive breast cancer. This change could potentially make the cancer more responsive to treatments that target estrogen receptors. Participants in the study will take Imatinib for a period of time before undergoing surgery to remove the breast cancer tissue. The researchers will then examine the removed tissue to determine if the cancer has converted to ER-positive.

Throughout the study, the safety of Imatinib will be monitored, and researchers will also look for markers that might predict whether the cancer will convert to ER-positive. This involves analyzing the molecular characteristics of the cancer, such as gene expression and immune response, both before starting Imatinib and after the surgery. The study aims to provide valuable insights into the potential of Imatinib as a treatment option for patients with triple negative breast cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to sign an informed consent form. This document confirms that you understand the study's purpose and procedures and agree to participate.
Step 2
Initial assessments
You will undergo initial assessments to confirm eligibility. These assessments include a review of your medical history and a physical examination.
A pregnancy test will be conducted if you are of childbearing potential. This test must be negative to proceed.
Step 3
Medication administration
You will begin taking the medication imatinib orally. The dosage and frequency will be determined by the study team and communicated to you.
It is important to take the medication as instructed and report any side effects to the study team.
Step 4
Ongoing monitoring
Throughout the study, you will have regular check-ups to monitor your health and the effects of the medication.
Blood tests and other assessments will be conducted to evaluate your response to the treatment.
Step 5
Surgery
At a specified point in the study, surgery will be performed to remove breast cancer tissue. This is a planned part of the study to assess the effect of the medication on the cancer.
Step 6
Post-treatment follow-up
After completing the medication course, you will have follow-up visits to monitor your recovery and any long-term effects of the treatment.
These visits will continue for up to 30 days after the last dose of imatinib.

Who can join the trial?

12 criteria

Must have a confirmed diagnosis of invasive primary triple negative breast cancer that is at least 15 mm in size.
Must be a female patient who can have children and agrees to use birth control methods with a very low failure rate during the study and for at least 90 days after the last dose of the study medication.
Must be able to swallow oral medication.
Must be able to understand the study requirements and have signed the consent form.
Must be at least 18 years old.
Must have a specific type of breast cancer called triple negative breast cancer, which means the cancer does not have certain receptors (ER, PR, and HER2) based on specific tests.
Must not have received any previous systemic treatment for triple negative breast cancer.
Must not be receiving any other anti-cancer treatment at the same time.
Can continue treatment with medications called Bisphosphonates, which are often used to strengthen bones.
Must have a good general health status, specifically an ECOG performance status of 0-1, which means fully active or restricted in physically strenuous activity but able to carry out light work.
Must have normal organ function, which includes specific levels of blood cells, liver enzymes, and kidney function.
If able to have children, must have a negative pregnancy test within 8 days before starting the study medication.

Who cannot join the trial?

4 criteria

Patients who do not have primary breast cancer cannot participate.
Patients who are not within the specified age range cannot participate. The age range includes young adults and middle-aged adults.
Both female and male patients can participate, but if you do not identify as either, you may not be eligible.
Patients who are considered part of a vulnerable population cannot participate. This means people who might need special protection or care.

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Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Gothenburg, Sweden

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Investigated drugs

Imatinib is a medication that is being tested in this clinical trial. It is usually used to treat certain types of cancer by blocking the proteins that help cancer cells grow. In this study, researchers are exploring whether Imatinib can change a type of breast cancer called triple negative breast cancer into a different type that is sensitive to hormones, specifically estrogen. This could potentially make the cancer easier to treat with hormone therapies.

Imatinib

What is already known about the treatment

Imatinib – Imatinib is administered orally in the form of a tablet. It is currently being studied in clinical trials for its potential to treat primary breast cancer, specifically aiming to convert triple-negative breast cancer into estrogen receptor (ER)-positive breast cancer. The main therapeutic indication for Imatinib in this context is to facilitate this conversion, which may open up new treatment options for patients. At the molecular level, Imatinib works by inhibiting certain proteins that are involved in cancer cell growth and survival. It is classified pharmacologically as a tyrosine kinase inhibitor, which means it blocks the action of enzymes that promote cancer cell proliferation.

Investigated diseases

Primary breast cancer – Primary breast cancer is a type of cancer that originates in the breast tissue. It typically begins in the cells of the milk-producing glands or the ducts that carry milk to the nipple. The disease progresses as cancer cells grow uncontrollably, forming a tumor that can be felt as a lump in the breast. Over time, these cancer cells can invade nearby tissues and spread to other parts of the body through the lymphatic system or bloodstream. The progression of primary breast cancer can vary, with some tumors growing slowly and others more rapidly. Hormonal factors, such as estrogen receptor status, can influence the behavior and growth rate of the cancer.